Women & Infants Hospital

Summary Statement of Deficiencies D0000 An onsite complaint survey was conducted at Women and Infants Transfusion Services for compliance with 42 CFR Part 493, Requirements for Laboratories. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on surveyor review of Transfusion Services Laboratory records and procedures and staff interviews, the laboratory failed to include detailed step-by-step processes in their approved Transfusion Services standard operating procedures (SOP) (refer to D5403) and testing personnel (TP) failed to follow approved Transfusion Services SOP (refer to 5401). The cumulative effect of these systematic problems resulted in the laboratory's inability to ensure the accuracy and reliability of Immunohematology results. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: A. Based on record review and staff interview on 07/29/2022, the laboratory staff Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- failed to follow the approved "Cord Blood Testing and Heel Specimens for ABO/RH & DAT, procedure # TRM.004.00.13 required for the review and release of blood products. Findings include: 1. Eight patient transfusion records with specific transfusion requirements were reviewed between January 2022 and July 2022. 2. Record review on 07/29/2022 of one of eight patient transfusion records (MRN: 008303744) in the PathNet BB Transfusion Patient Product Laboratory Information System (LIS) revealed the following in the "Blood Bank Comments" field: a. >>JUN /15122 09:00 00 cord tested 6/9 b. " JUN/11/22 14:-16:00 Heel type performed 06/11 /2022 14 46:25 EDT 3. Record review on 07/29/2022 of the Cord Blood Testing and Heel Specimens for ABO/RH & DAT, procedure # TRM 004.00.13 approved on 02/20 /2017 revealed the following under the section titled, "ABO/Rh Confirmation of Heel Specimens - for babies with orders for blood" a. "5. Place a comment under the comment section in Patient Product History giving the status of a retype and if O negative cells must be given." 4. Staff interview with the General Supervisor (GS#2) on 07/29/2022 at 11:03 AM confirmed that TP#1 failed to follow the procedure noted above for entering patient comments required for the review and release of blood products. The interview further revealed that the neonatal patient (MRN:008303744) received type O positive red cells on 06/15/2022. The GS#2 further revealed the patient's mom is O negative with positive screen due to Rhogam. For transfusion purposes, the patient should have received Rh negative red cells and platelets. 5. Staff interview with GS#2 on 07/29/2022 at 3:30 PM revealed that the laboratory performs an estimated total of 450 transfusions per year. A smaller portion of these includes specific transfusion requirements. B. Based on record review and staff interview on 07 /29/2022, the laboratory staff failed to follow the approved "Selection of Blood and Blood Products for Neonate" Procedure # TRM 006.18.12 before dispensing and releasing blood products. Findings include: 1. Eight patient transfusion records with specific transfusion requirements were reviewed between January and July 2022. 2. Record review on 07/29/2022 of patient record MRN:008303620 in the PathNet BB Transfusion Patient Product revealed the following comment under the "Blood Bank Comments" section: a. >>JUN.124/22 10:16: Infant must receive Rh Neg cellular products b. >> JUN/23122 12:29:00 Mom O neg pos screen Anti-D due to RHIG 06121/22 2x cord and heel on 06/23/22. 3. Record review on 07/29/2022 of "Selection of Blood and Blood Products for Neonate" Procedure # TRM 006.18.12, revealed "If the mother of a neonate demonstrates anti-D, provide the neonate with Rh negative platelets" under Section E Selection of Platelets for Transfusion. 4. Staff interview with General Supervisor (GS#2) on 07/29/2022 at 11:18 AM confirmed that the neonatal patient MRN:008303620 received B positive platelets on 06/24/2022. GS#2 stated platelets were issued by TP#3 at 1:00 AM and TP#2 prepared the syringe. TP#5 saw the platelets on the rotator at 10:00 AM on 06/25/2022 and discovered the patient received the wrong product. TP#5 reported this to the GS#2. The interview further revealed that testing personnel (TP#2 and TP#3) failed to follow the procedure noted above before reviewing and dispensing the blood products. GS#2 confirmed the patient's mother had a O negative blood type and a positive screen due to Rhogam, meaning for transfusion purposes, the infant should have received Rh negative products. C. Based on record review and staff interview on 07/29/2022, the laboratory staff failed to follow the approved "Dispense and Assign" Procedure # TRM.C013. 00.10 before dispensing and releasing blood products. Findings include: 1. Eight patient transfusion records with specific transfusion requirements were reviewed between January 2022 and July 2022. 2. Record review on 07/29/2022 of patient record MRN: 008090614 in PathNet BB Transfusion Patient Product Laboratory Information System (LIS) revealed the following comment under the "Blood Bank Comments" section: "TRANSFUSE O CELLS ONLY Patient is a subgroup A2 with an Anti-A1" 3. Record review on 07/29/2022 of "Dispense and Assign" procedure # -- 2 of 4 -- TRM.C013.00.10 revealed "under section B Dispense, "6. Click on the yellow Comment icon (paperclip) and open the comments in the screen. Adjust the comment box so it is big enough for all the comments to be seen all at once." "Note: It is very important that the comments found in this area are followed. If the product being dispensed does not match these comments, do not release the product and select one that is more appropriate." 4. Staff interview with General Supervisor (GS#2) on 07/29 /2022 at 11:38 AM confirmed that the patient MRN: 008090614 received 3 units of A positive cells on 07/05/2022. The interview further revealed that testing personnel (TP#7 and TP#8) failed to follow the procedure noted above before reviewing and dispensing the blood products. The GS#2 also stated that the patient is A subgroup, and needed to receive O cells for transfusions. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)